A
Goodmorning!
Thank you for all the help this forum gave me. I need some direction, hopefully somebody can help me with this:
We develop and manufacture medical devices; class 1 (EU) class2 (USA). Since we start to export to the USA, I would like to reorganize the DHF's.
We have about 500 sellingcodes, all different configurations of- or accessories to the parent medical devices. These can be divided into 3 groups with each their own intended use. So I was planning to create 3 main DHF's which include the most complex and risk full devices, the parent devices. (about 30) I can include the requirements, risk analysis, verification, validation etc for those devices.
But how can I prove a FDA auditor that we planned and controlled the design of the other configurations and accessories? An excel list with references?
Thank you for your support!
Thank you for all the help this forum gave me. I need some direction, hopefully somebody can help me with this:
We develop and manufacture medical devices; class 1 (EU) class2 (USA). Since we start to export to the USA, I would like to reorganize the DHF's.
We have about 500 sellingcodes, all different configurations of- or accessories to the parent medical devices. These can be divided into 3 groups with each their own intended use. So I was planning to create 3 main DHF's which include the most complex and risk full devices, the parent devices. (about 30) I can include the requirements, risk analysis, verification, validation etc for those devices.
But how can I prove a FDA auditor that we planned and controlled the design of the other configurations and accessories? An excel list with references?
Thank you for your support!